ZANTAC 150 MAXIMUM STRENGTH COOL MINT- ranitidine hydrochloride tablet, film coated

Zantac 150 by

Drug Labeling and Warnings

Zantac 150 by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Zantac 150 Cool Mint Tablets

Drug Facts

Active ingredient (in each tablet) 

Ranitidine 150 mg (as ranitidine hydrochloride 168 mg)

Purpose

Acid reducer

Uses

■ relieves heartburn associated with acid indigestion and sour stomach  

■ prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages  

Warnings

Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers

Do not use  

■ if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.  

■ with other acid reducers

■ if you have kidney disease, except under the advice and supervision of a doctor

Ask a doctor before use if you have  

■ had heartburn over 3 months. This may be a sign of a more serious condition.  

■ heartburn with lightheadedness, sweating or dizziness

■ chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness

■ frequent chest pain ■ frequent wheezing, particularly with heartburn ■ unexplained weight loss

■ nausea or vomiting ■ stomach pain  

Stop use and ask a doctor if

■ your heartburn continues or worsens

■ you need to take this product for more than 14 days

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

■ adults and children 12 years and over:  

      ■ to relieve symptoms, swallow 1 tablet with a glass of water

      ■ to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn

      ■ can be used up to twice daily (do not take more than 2 tablets in 24 hours) ■ do not chew tablet

■ children under 12 years: ask a doctor

Other information

■ do not use if printed foil under bottle cap is open or torn ■ store at 20-25°C (68-77°F)

■ avoid excessive heat or humidity       ■ this product is sodium and sugar free

Inactive ingredients

FD&C Blue No. 1, flavors, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sucralose, titanium dioxide

Questions?

call 1-800-633-1610 or visit www.zantacotc.com

Read the directions, consumer information leaflet and warnings before use. Keep the carton. It contains important information.

PRINCIPAL DISPLAY PANEL

Cool Mint TABLETS
Maximum Strength
Zantac
150
40 Tablets

INGREDIENTS AND APPEARANCE

ZANTAC 150  MAXIMUM STRENGTH COOL MINT
ranitidine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0320
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7)	RANITIDINE	150 mg

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SUCRALOSE (UNII: 96K6UQ3ZD4)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)

Product Characteristics
Color	BLUE	Score	no score
Shape	PENTAGON (5 SIDED)	Size	4mm
Flavor		Imprint Code	Z;150
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0320-1	1 in 1 CARTON	09/23/2018
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 41167-0320-2	3 in 1 CARTON	09/23/2018
2		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 41167-0320-0	4 in 1 CARTON	07/26/2018
3		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 41167-0320-6	1 in 1 CARTON	01/04/2018
4		40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
5	NDC: 41167-0320-3	1 in 1 CARTON	01/04/2018
5		50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
6	NDC: 41167-0320-4	1 in 1 CARTON	01/04/2018
6		65 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
7	NDC: 41167-0320-7	1 in 1 CARTON	01/04/2018
7		78 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
8	NDC: 41167-0320-5	1 in 1 CARTON	01/04/2018
8		90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021698	01/04/2018

Labeler - Chattem, Inc. (003336013)